Batch Verification Report
Batch verification and analytical data for BPC-157.
Manufacture date: 16 Oct 2025
Recommended retest date: 15 Oct 2027
Amount: As specified on Celvaris product label
Analytical Data
The following analytical tests were performed by the manufacturer on batch P250927-A015. All data presented in this Batch Verification Report reflects manufacturer testing results.
| Test | Method | Specification | Result |
|---|---|---|---|
| Identity | MS (ESI) | Conforms to reference | Conforms |
| Purity | HPLC | ≥ 98.0% | 98.69% |
| Peptide content (N%) | Elemental nitrogen | ≥ 80.0% | 95.71% |
| Appearance | Visual | White powder | Conforms |
| Water content | Karl Fischer | ≤ 10.0% | 3.04% |
| Acetate content | HPLC | < 12.0% | 0.66% |
| Residual solvent – Acetonitrile | GC | NMT 410 ppm | Not detected |
| Residual solvent – Methanol | GC | NMT 3000 ppm | Not detected |
| Total aerobic microbial count | Plate count | ≤ 1000 cfu/g | Conforms |
| Total yeast & mold count | Plate count | ≤ 200 cfu/g | Conforms |
| Mass balance | Calculated | 95.0–105.0% | 99.41% |
Storage & Handling
Storage Conditions:
- Store at -20°C or below in original sealed vial
- Protect from light and moisture
- Do not freeze-thaw repeatedly once reconstituted
- Recommended shelf life: 24 months when stored properly
General Laboratory Handling:
- Handle using standard laboratory safety practices
- Wear appropriate personal protective equipment (gloves, lab coat, safety glasses)
- Use in well-ventilated area or fume hood
- Avoid inhalation, ingestion, or skin/eye contact
- Wash hands thoroughly after handling
Reconstitution:
Reconstitution methods, diluents, and working concentrations must be determined by qualified researchers
according to their specific experimental protocols and institutional guidelines. Celvaris does not provide
reconstitution instructions.
Additional Information:
For questions about this batch or to request additional information, contact
[email protected]
Note: Any deviations from the above specification, if present, will be explicitly noted. In the absence of such notes, all parameters conform to the stated limits.